Thursday, September 29, 2011

The Long and Short of Checklists

Checklists have become a popular mechanism for ensuring that IRBs or IRB members cover all necessary issues in review of research. Contrary to what some believe, AAHRPP does not require the use of checklists, but it does recognize checklists as one of many ways of fulfilling regulatory responsibilities. Should an organization opt to use checklists, AAHRPP requires the checklists to be correct and complete.

Checklists, however, must never take the place of thoughtful discussion, debate, and decision making. For example, in the review of a clinical trial that proposes to enroll women of childbearing age, pregnant women might be enrolled if not excluded or women might become pregnant while enrolled in the trial. Checking boxes on a list that covers the requirements in Subpart B would not met those requirements when considering such issues as the risk-benefit analysis for pregnant women and fetuses or embryos. There should be a discussion of the risk to pregnant women and embryos or fetuses, a decision about whether pregnant women should be included, and, based on the risk, a plan for how pregnant women should be excluded (for example, asking about pregnancy status versus a urine pregnancy test). A checklist should guide these discussions or record the results of the discussion but should not be used merely to mark the boxes without careful consideration.

Another example is documenting the criteria for a waiver of the consent process. It is not enough for the reviewer to put a check by each of the four criteria for a waiver of consent to justify that they are satisfied. A protocol-specific determination must be made and documented to explain why each criterion is met for the specific research project:

  • Why does the research meet the criterion for no greater than minimal risk?
  • Why does the waiver not adversely affect the rights and welfare of the participants?
  • Why is it that the research could not practicably be carried out without the waiver? 
  • Will the participants be provided with additional pertinent information after participation? If so, how? Is this appropriate?

As an IRB member, when you have to provide justification for a waiver, you might discover that you cannot make a determination based on the information provided in the protocol by the researcher. It is acceptable for the researcher to provide the protocol-specific justification for the waiver and for the convened IRB or reviewer to accept or agree with the justification and then, ultimately, document the agreement. In that case both the protocol-specific determinations and the agreement by the IRB or reviewer must appear in the IRB minutes or records.
This is not to say that every item on a checklist needs to have written determinations, and in fact many may not need any explanation; for example, when the answer to “Are prisoners included?” is “No.” One must be cognizant, though, of the key criteria that do need written determinations—usually the criteria for approval, waivers, and subpart determinations. Basically, a determination or “check” that needs an explanation should be documented. Write enough information in your records for other viewers to understand the decision making.

Checklists are useful, but only when combined with thoughtful decision making, debate when appropriate, and documentation of protocol-specific determinations.

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